Obstructive sleep apnoea/ hypopnoea syndrome and obesity hypoventilation syndrome in over 16s - NICE
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National Institute for Health and Care
Excellence
Draft
Obstructive sleep apnoea/
hypopnoea syndrome and
obesity hypoventilation
syndrome in over 16s
Evidence review M: Demonstration of efficacy
NICE guideline
Intervention evidence review
March 2021
Draft for Consultation
Developed by the National Guideline CentreOSAHS: DRAFT FOR CONSULTATION
Contents
1
Disclaimer
The recommendations in this guideline represent the view of NICE, arrived at after careful
consideration of the evidence available. When exercising their judgement, professionals are
expected to take this guideline fully into account, alongside the individual needs, preferences
and values of their patients or service users. The recommendations in this guideline are not
mandatory and the guideline does not override the responsibility of healthcare professionals
to make decisions appropriate to the circumstances of the individual patient, in consultation
with the patient and, where appropriate, their carer or guardian.
Local commissioners and providers have a responsibility to enable the guideline to be
applied when individual health professionals and their patients or service users wish to use it.
They should do so in the context of local and national priorities for funding and developing
services, and in light of their duties to have due regard to the need to eliminate unlawful
discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing
in this guideline should be interpreted in a way that would be inconsistent with compliance
with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK
countries are made by ministers in the Welsh Government, Scottish Government, and
Northern Ireland Executive. All NICE guidance is subject to regular review and may be
updated or withdrawn.
Copyright
© NICE 2021. All rights reserved. Subject to Notice of rights.OSAHS: DRAFT FOR CONSULTATION
Contents
Contents
1 Demonstration of efficacy............................................................................................ 5
1.1 Review question: How should efficacy of treatment be demonstrated? ................. 5
1.2 Introduction ........................................................................................................... 5
1.3 PICO table............................................................................................................. 5
1.4 Clinical evidence ................................................................................................... 6
1.4.1 Included studies ......................................................................................... 6
1.4.2 Summary of clinical studies included in the evidence review ...................... 6
1.4.3 Quality assessment of clinical studies included in the evidence review ...... 6
1.5 Economic evidence ............................................................................................... 6
1.5.1 Included studies ......................................................................................... 6
1.5.2 Excluded studies ........................................................................................ 6
1.5.3 Health economic modelling ........................................................................ 6
1.5.4 Health economic evidence statements ....................................................... 6
1.6 The committee’s discussion of the evidence.......................................................... 7
1.6.1 Interpreting the evidence............................................................................ 7
1.6.2 The outcomes that matter most .................................................................. 7
1.6.3 The quality of the evidence ........................................................................ 7
1.6.4 Benefits and harms .................................................................................... 7
Appendices ........................................................................................................................ 15
Appendix A: Review protocols ................................................................................... 15
Appendix B: Literature search strategies ................................................................... 22
Appendix C: Clinical evidence selection ..................................................................... 33
Appendix D: Clinical evidence tables ......................................................................... 34
Appendix E: Forest Plots ........................................................................................... 34
Appendix F: GRADE tables ....................................................................................... 34
Appendix G: Health economic evidence selection ...................................................... 35
Appendix H: Excluded studies.................................................................................... 36
1
4OSAHS: DRAFT FOR CONSULTATION
Review protocols
1 1 Demonstration of efficacy
2 1.1 Review question: How should efficacy of treatment be
3 demonstrated?
4 1.2 Introduction
5 Having embarked on treatment for obstructive sleep apnoea/hypopnoea syndrome (OSAHS),
6 obesity hypoventilation syndrome (OHS) and COPD-OSAHS overlap syndrome, it is
7 important to assess whether this is working or if further therapy modifications are required.
8 There has not been a standardised approach to this, nor have there been national
9 guidelines, so practice varies between centres. Some have had a symptom focussed
10 approach to assessing treatment efficacy, others have performed repeat sleep studies,
11 others have used data available from downloads of positive airway pressure therapy. Newer
12 widely available CPAP machines and telemonitoring allow more data on overnight sleep
13 disordered breathing to be collected and potentially easily reviewed.
14 1.3 PICO table
15 For full details see the review protocol in appendix A.
16 Table 1: PICO characteristics of review question
Population People being treated for OSAHS/OHS/ COPD-OSAHS overlap syndrome,
stratified by:
• disease severity (mild vs moderate vs severe)
• condition (OSAHS/OHS/ COPD-OSAHS overlap syndrome)
• type of treatment (CPAP vs surgery vs positional modifiers vs oral devices)
Interventions • using ESS (Epworth Sleepiness Scale)
• using AHI (Apnoea Hypopnea Index)
• using ODI (Oxygen desaturation index)
• using SAQLI (Calgary Sleep Apnea Quality of Life Index)
• using partner reported symptoms
• using hours of use
• using ABG based CO2 monitoring (for OHS only)
• using transcutaneous CO2 monitoring (for OHS only)
Treatment to be adjusted during the period of measurements
Comparisons Any of the above vs any other in isolation or combination
Outcomes Critical
• generic or disease specific quality of life measures (continuous)
• mortality (dichotomous)
Important
• sleepiness scores (continuous, e.g. Epworth)
• apnoea-hypopnoea index (continuous)
• oxygen desaturation index (continuous)
• CO2 control (continuous)
• hours of use (adherence measure, continuous)
• minor adverse effects of treatment (rates or dichotomous)
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5OSAHS: DRAFT FOR CONSULTATION
Review protocols
• driving outcomes (continuous)
• neurocognitive outcomes (continuous)
• impact on co-existing conditions:
o HbA1c for diabetes (continuous)
o cardiovascular events for cardiovascular disease (dichotomous)
o systolic blood pressure for hypertension (continuous)
All follow-up times will be included. Follow-up times will be grouped as: follow-up
1 year
Study design • RCTs
Minimum follow-up 1 month
1 1.4 Clinical evidence
2 1.4.1 Included studies
3 A search was conducted for studies on markers/indices/ measures to monitor treatment in
4 patients with OSAHS/OHS/ COPD-OSAHS overlap syndrome. No relevant studies were
5 identified.
6 See the excluded studies list in appendix I.
7 1.4.2 Summary of clinical studies included in the evidence review
8 No studies included in the review.
9 1.4.3 Quality assessment of clinical studies included in the evidence review
10 No studies included in the review.
11 1.5 Economic evidence
12 1.5.1 Included studies
13 No health economic studies were included.
14 1.5.2 Excluded studies
15 No relevant health economic studies were excluded due to assessment of limited
16 applicability or methodological limitations.
17 See also the health economic study selection flow chart in appendix G.
18 1.5.3 Health economic modelling
19 Original modelling was not conducted for this question.
20 1.5.4 Health economic evidence statements
21 No relevant economic evaluations were identified.
22
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6OSAHS: DRAFT FOR CONSULTATION
Review protocols
1 1.6 The committee’s discussion of the evidence
2 1.6.1 Interpreting the evidence
3 1.6.1.1 The outcomes that matter most
4 The committee considered the outcomes of health-related quality of life and mortality as
5 critical outcomes for decision making. Other important outcomes included sleepiness scores
6 (continuous, e.g. Epworth), apnoea-hypopnoea index, oxygen desaturation index, CO2
7 control, hours of use (adherence measure), minor adverse effects of treatment, driving
8 outcomes, neurocognitive outcomes, impact on co-existing conditions, HbA1c for diabetes,
9 cardiovascular events for cardiovascular disease, systolic blood pressure for hypertension.
10 There was no evidence available for any of the outcomes.
11 1.6.1.2 The quality of the evidence
12 No evidence was available for this review question.
13 1.6.2 Benefits and harms
14 OSAHS (CPAP, oral devices, positional modifiers)
15 There was no evidence on demonstrating efficacy for treatments for people with OSAHS, so
16 the guideline committee made recommendations based on their experience and knowledge
17 of current best practice.
18 The committee discussed that an ideal measure of treatment efficacy would demonstrate
19 control of symptoms, control of AHI and uptake and adherence to therapy. The committee
20 noted that there was a huge variation in practice in the use of monitoring methods/measures.
21 The committee agreed that clinicians would want optimal control of symptoms after
22 treatment. The symptoms could be snoring, witnessed apnoea, unrefreshing sleep,
23 excessive sleepiness, nocturia, tiredness, insomnia, headaches, sleep fragmentation, ankle
24 swelling, and cognitive dysfunction/memory impairment. However, they agreed that
25 treatment efficacy cannot be decided on improvements of symptoms alone as it is an
26 imprecise indicator of treatment success and some may be symptom-free at the outset.
27 The committee discussed that objective measures such as AHI should be used to assess the
28 efficacy of CPAP/mandibular advancement splint /positional modifier treatment. The
29 committee did not want to prescribe a threshold for AHI but agreed that the aim of the
30 treatment is to achieve AHIOSAHS: DRAFT FOR CONSULTATION
Review protocols
1 The committee agreed that in people using CPAP their understanding and experience of
2 treatment should be explored, and mask fit/leak, cleaning and maintaining equipment, nasal
3 and mouth dryness, as well as other factors affecting sleep disturbance such as insomnia,
4 restless legs, sleep hygiene, shift work, sleep routines should be reviewed. Careful history
5 taking is required and further detailed investigation may be needed in some cases (for
6 example polysomnography, monitoring of limb movements, or actigraphy), particularly when
7 additional non-respiratory sleep disorders are suspected.
8 The committee noted that CPAP is just one aspect of the treatment for OSAHS, and that
9 monitoring should be tailored to the person’s overall treatment plan, which may include
10 lifestyle changes and weight management, modifying sedative drugs and alcohol, stopping
11 smoking, and treating underlying lung disease and other comorbidities.
12 The committee discussed that reviewing symptoms as well as ESS, AHI and adherence to
13 therapy is current practice and implementation of these recommendations will not change
14 practice.
15 The committee agreed that if other therapies for OSAHS are used, such as customised
16 mandibular advancement splint, or positional modifiers then assessment of their
17 effectiveness should be measured once treatment has been optimised (e.g. after 3 months):
18 on symptoms including ESS, and AHI measured by repeat sleep study.
19 Even though there was a lack of evidence on demonstrating efficacy for treatments for
20 people with OSAHS, based on their experience the committee made strong
21 recommendations hence they did not make any research recommendation for this topic.
22
23 OHS (non-invasive ventilation, CPAP)
24 There was no evidence for demonstrating efficacy for treatments for OHS, so the guideline
25 committee made recommendations based on their experience and knowledge of current best
26 practice. In OHS control of hypoventilation is demonstrated by improvement of symptoms,
27 hypercapnia when awake and asleep, and oxygenation. It is important to optimise these in
28 order to improve well-being and prognosis, and to reduce the risk of hospital admission.
29 The committee agreed that clinical effectiveness of treatment (CPAP/non-invasive
30 ventilation) in people with OHS should be assessed by reviewing: symptoms of OSAHS and
31 hypoventilation including ESS, AHI, adherence to therapy, an assessment of improvement in
32 oxygenation and hypercapnia while awake and asleep and telemonitoring or download
33 information from CPAP or non-invasive ventilation device.
34 The committee agreed that in people using CPAP their understanding and experience of
35 treatment should be explored, and mask fit/leak, cleaning and maintenance of equipment,
36 nasal and mouth dryness, other factors affecting sleep disturbance such as insomnia,
37 restless legs, sleep hygiene, shift work, sleep routines should be reviewed.
38 The committee highlighted that in people with OHS, the need for oxygen therapy and
39 adherence to this should be reviewed after treatment with non-invasive ventilation or CPAP
40 has been optimised.
41 The committee noted that CPAP and non-invasive ventilation are just part the treatment for
42 OHS, and that monitoring should be tailored to the person’s overall treatment plan, which
43 should also include lifestyle changes and weight management, modifying sedative drugs and
44 alcohol, stopping smoking, and treating underlying lung disease and other comorbidities. The
45 committee discussed that reviewing symptoms including ESS, AHI and adherence to therapy
46 is current practice and implementation of these recommendations will not change practice.
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8OSAHS: DRAFT FOR CONSULTATION
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1 The committee highlighted that in people with OHS, non-invasive ventilation or CPAP should
2 be optimised first before reviewing requirement for long term oxygen therapy.
3 Even though there was a lack of evidence on demonstrating efficacy for treatments for
4 people with OHS, based on their experience the committee made strong recommendations
5 hence they did not make any research recommendation for this topic.
6
7 COPD-OSAHS overlap syndrome (non-invasive ventilation, CPAP, oxygen therapy)
8 COPD-OSAHS overlap syndrome is defined by the presence of COPD and OSAHS.
9 Treatment for overlap syndrome is to address underlying COPD, OSA, or both.
10 There was no evidence for demonstrating efficacy for treatments for COPD-OSAHS overlap
11 syndrome, so the guideline committee made recommendations based on their experience
12 and knowledge of current best practice.
13 In COPD-OSAHS overlap syndrome, control of hypoventilation is demonstrated by
14 improvement of daytime and night time oxygenation and hypercapnia; this is important to
15 improve prognosis.
16 The committee agreed that clinical effectiveness of treatment (CPAP/non-invasive
17 ventilation) in people with COPD-OSAHS overlap syndrome should be assessed by
18 reviewing: symptoms of OSAHS and hypoventilation including ESS, AHI, adherence to
19 therapy, improvement in oxygenation and hypercapnia (if present) while awake and asleep ,
20 if present and telemonitoring or download information from CPAP or non-invasive ventilation
21 device.
22 The committee agreed that in people using CPAP their understanding and experience of
23 treatment should be explored, and mask fit/leak, nasal and mouth dryness, other factors
24 affecting sleep disturbance such as insomnia, restless legs, sleep hygiene, shift work, sleep
25 routines should be reviewed. They noted that sleep quality may be poor in COPD patients,
26 with disruption from cough, wheeze, restless legs and medication.
27 In some patients with severe COPD and COPD-OSAHS overlap syndrome optimised
28 treatment of the OSAHS may produce an objective improvement in indices such as the AHI
29 or oxygen desaturation during sleep but fail to improve symptoms or quality of life for the
30 patient. This would usually be because the severity of the person’s COPD has the over-riding
31 influence on quality of life. Since use of non-invasive ventilation or CPAP equipment adds to
32 the burden of therapy, consideration should be given to the stopping these and using a
33 symptom management approach. This requires careful discussion with the patient and their
34 care givers, may also include discussions care planning (for example COPD exacerbation
35 action plan and advance care planning) for those with severe COPD. The committee
36 discussed that reviewing symptoms/sleepiness and adherence to therapy is current practice
37 and implementation of these recommendations will not change practice.
38 The committee highlighted that in people with COPD-OSAHS overlap syndrome who are
39 already having supplemental oxygen therapy, the need for oxygen therapy should be
40 reviewed after treatment with non-invasive ventilation or CPAP has been optimised. Effective
41 treatment with CPAP or non-invasive ventilation may improve the person’s condition to the
42 extent that they no longer fulfil the criteria for supplemental oxygen.
43 Even though there was a lack of evidence on demonstrating efficacy for treatments for
44 people with COPD-OSAHS overlap syndrome, based on their experience the committee
45 made strong recommendations hence they did not make any research recommendation for
46 this topic.
47
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9OSAHS: DRAFT FOR CONSULTATION
Review protocols
1 1.6.3 Cost effectiveness and resource use
2 There were no economic or clinical evaluations identified for this review question. The
3 committee therefore made consensus recommendations based on current practice.
4 Since treatments in these conditions are potentially for life it is important for cost
5 effectiveness as well as for patient welfare to assess whether a treatment is working and
6 then, if necessary, to modify or discontinue treatment.
7 The committee recommended assessing symptom control and, especially for CPAP and non-
8 invasive ventilation factors that affect adherence. These assessments are already current
9 practice. The frequency of monitoring is discussed in evidence report L.
10 Although control of symptoms is important, the committee agreed that treatment efficacy
11 cannot be decided on improvements of symptoms alone as they are an imprecise indicator of
12 treatment success and some people may be symptom-free at the outset. Therefore, they
13 recommended the re-assessment of severity of OSAHS using AHI. For patients being treated
14 with CPAP or non-invasive ventilation this is downloaded from the device itself and can be
15 done remotely where there is telemonitoring – see Chapter L. However, for patients receiving
16 other treatments this might require a home or hospital sleep study. For patients with OHS or
17 overlap syndrome an assessment of improvement in oxygenation and hypercapnia would
18 also be required.
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10OSAHS: DRAFT FOR CONSULTATION
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26 47. Sutherland K, Phillips CL, Davies A, Srinivasan VK, Dalci O, Yee BJ et al. CPAP
27 pressure for prediction of oral appliance treatment response in obstructive sleep
28 apnea. Journal of Clinical Sleep Medicine. 2014; 10(9):943-949
29 48. Suzuki M, Saigusa H, Kurogi R, Morita S, Ishizuka Y. Postoperative monitoring of
30 esophageal pressure in patients with obstructive sleep apnea-hypopnea syndrome
31 who have undergone tonsillectomy with uvulopalatopharyngoplasty. Annals of
32 Otology, Rhinology and Laryngology. 2008; 117(11):849-853
33 49. Tam S, Woodson BT, Rotenberg B. Outcome measurements in obstructive sleep
34 apnea: beyond the apnea-hypopnea index. Laryngoscope. 2014; 124(1):337-343
35 50. Tedeschi E, Carratu P, Damiani MF, Ventura VA, Drigo R, Enzo E et al. Home
36 unattended portable monitoring and automatic CPAP titration in patients with high risk
37 for moderate to severe obstructive sleep apnea. Respiratory Care. 2013; 58(7):1178-
38 1183
39 51. Trikalinos TA, Ip S, Raman G, Cepeda MS, Balk EM, D'Ambrosio C et al. Home
40 diagnosis of obstructive sleep apnea-hypopnea syndrome. Rockville, MD. Agency for
41 Healthcare Research and Quality (US), 2007. Available from:
42 https://www.ncbi.nlm.nih.gov/books/NBK254138/pdf/Bookshelf_NBK254138.pdf
43
44
45
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14OSAHS: DRAFT FOR CONSULTATION
Review protocols
1 Appendices
2 Appendix A: Review protocols
3 Table 2: Review protocol: demonstration of efficacy
Field Content
PROSPERO registration Not registered
number
Review title Demonstration of efficacy
Review question How should efficacy of treatment be demonstrated (for example, variable
positive pressure titration device, oximetry, capnography or
polysomnography titration)?
Objective Determine the most clinically and cost-effective marker/index/ measure to
monitor treatment in patients with OSAHS/OHS/COPD-OSAHS overlap
syndrome.
Searches The following databases (from inception) will be searched:
• Cochrane Central Register of Controlled Trials (CENTRAL)
• Cochrane Database of Systematic Reviews (CDSR)
• Embase
• MEDLINE
• Epistemonikos
The searches may be re-run 6 weeks before the final committee meeting
and further studies retrieved for inclusion if relevant.
The full search strategies will be published in the final review.
Condition or domain Obstructive sleep apnoea/hypopnoea syndrome is the most common form
being studied of sleep disordered breathing. The guideline will also cover obesity
hypoventilation syndrome and COPD-OSAHS overlap syndrome (the
coexistence of obstructive sleep apnoea/hypopnoea syndrome and chronic
obstructive pulmonary disease).
Population Inclusion:
People being treated for OSAHS/OHS/ COPD-OSAHS overlap syndrome,
stratified by:
• Disease severity (mild vs moderate vs severe)
• Condition (OSAHS/OHS/ COPD-OSAHS overlap syndrome)
• Type of treatment (CPAP vs surgery vs positional modifiers vs oral
devices)
Severity:
• Mild OSAHS: AHI >5 but /= 15 but /= 30
When a mixed severity population is included the severity of the majority of
the population will be used by taking the mean AHI of the patients
included and the study will be downgraded for indirectness.
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15OSAHS: DRAFT FOR CONSULTATION
Review protocols
Intervention/Exposure/Te • Using ESS (Epworth Sleepiness Scale)
st
• Using AHI (Apnoea Hypopnea Index)
• Using ODI (Oxygen desaturation index)
• Using SAQLI (Calgary Sleep Apnea Quality of Life Index)
• Using partner reported symptoms
• Using hours of use
• Using ABG based CO2 monitoring (for OHS only)
• Using transcutaneous CO2 monitoring (for OHS only)
Treatment to be adjusted during the period of measurements
Comparator/Reference Any of the above vs any other in isolation or combination
standard/Confounding
factors
Types of study to be • RCTs
included
Minimum follow-up 1 month
Other exclusion criteria Non-English language studies.
Conference abstracts
Context -
Primary outcomes (critical • Generic or disease specific quality of life measures (continuous)
outcomes) • Mortality (dichotomous)
All follow-up times will be included. Follow-up times will be grouped as:
follow-up 1 year
Secondary outcomes • Sleepiness scores (continuous, e.g. Epworth)
(important outcomes) • Apnoea-Hypopnoea index (continuous)
• Oxygen desaturation index (continuous)
• CO2 control (continuous)
• Hours of use (adherence measure, continuous)
• Minor adverse effects of treatment (rates or dichotomous)
• Driving outcomes (continuous)
• Neurocognitive outcomes (continuous)
• Impact on co-existing conditions:
o HbA1c for diabetes (continuous)
o Cardiovascular events for cardiovascular disease (dichotomous)
o Systolic blood pressure for hypertension (continuous)
All follow-up times will be included. Follow-up times will be grouped as:
follow-up 1 year
Data extraction (selection EndNote will be used for reference management, sifting, citations and
and coding) bibliographies. All references identified by the searches and from other
sources will be screened for inclusion. 10% of the abstracts will be reviewed
by two reviewers, with any disagreements resolved by discussion or, if
necessary, a third independent reviewer. The full text of potentially eligible
studies will be retrieved and will be assessed in line with the criteria outlined
above.
EviBASE will be used for data extraction.
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16OSAHS: DRAFT FOR CONSULTATION
Review protocols
Risk of bias (quality) Risk of bias will be assessed using the appropriate checklist as described in
assessment Developing NICE guidelines: the manual.
• Systematic reviews: Risk of Bias in Systematic Reviews (ROBIS)
• Randomised Controlled Trial: Cochrane RoB (2.0)
10% of all evidence reviews are quality assured by a senior research fellow.
This includes checking:
• papers were included /excluded appropriately
• a sample of the data extractions
• correct methods are used to synthesise data
• a sample of the risk of bias assessments
Disagreements between the review authors over the risk of bias in particular
studies will be resolved by discussion, with involvement of a third review
author where necessary.
Strategy for data Pairwise meta-analyses will be performed using Cochrane Review Manager
synthesis (RevMan5).
• GRADEpro will be used to assess the quality of evidence for each
outcome, taking into account individual study quality and the meta-
analysis results. The 4 main quality elements (risk of bias, indirectness,
inconsistency and imprecision) will be appraised for each outcome.
Publication bias is tested for when there are more than 5 studies for an
outcome.
The risk of bias across all available evidence was evaluated for each
outcome using an adaptation of the ‘Grading of Recommendations
Assessment, Development and Evaluation (GRADE) toolbox’ developed by
the international GRADE working group http://www.gradeworkinggroup.org/
Where meta-analysis is not possible, data will be presented and quality
assessed individually per outcome.
• WinBUGS will be used for network meta-analysis, if possible given the
data identified.
Heterogeneity between the studies in effect measures will be assessed
using the I² statistic and visually inspected. An I² value greater than 50% will
be considered indicative of substantial heterogeneity. Sensitivity analyses
will be conducted based on pre-specified subgroups using stratified meta-
analysis to explore the heterogeneity in effect estimates. If this does not
explain the heterogeneity, the results will be presented pooled using
random-effects.
Analysis of sub-groups Subgroups that will be investigated if heterogeneity is present:
• High risk occupational groups (for example heavy goods vehicle drivers)
vs general population
• Sleepiness – Epworth >9 vs Epworth 9 or less
• Coexisting conditions – type 2 diabetes vs atrial fibrillation vs
hypertension vs none
• BMI – obese vs non-obese
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17OSAHS: DRAFT FOR CONSULTATION
Review protocols
Type and method of ☒ Intervention
review
☐ Diagnostic
☐ Prognostic
☐ Qualitative
☐ Epidemiologic
☐ Service Delivery
☐ Other (please specify)
Language English
Country England
Anticipated or actual start NA – not registered on PROSPERO
date
Anticipated completion NA – not registered on PROSPERO
date
Named contact 5a. Named contact
National Guideline Centre
5b Named contact e-mail
SleepApnoHypo@nice.org.uk
5e Organisational affiliation of the review
National Institute for Health and Care Excellence (NICE) and the National
Guideline Centre
Review team members From the National Guideline Centre:
Carlos Sharpin, Guideline lead
Sharangini Rajesh, Senior systematic reviewer
Audrius Stonkus, Systematic reviewer
Emtiyaz Chowdhury (until January 2020), Health economist
David Wonderling, Head of health economics
Agnes Cuyas, Information specialist (till December 2019)
Jill Cobb, Information specialist
Funding sources/sponsor This systematic review is being completed by the National Guideline Centre
which receives funding from NICE.
Conflicts of interest All guideline committee members and anyone who has direct input into
NICE guidelines (including the evidence review team and expert witnesses)
must declare any potential conflicts of interest in line with NICE's code of
practice for declaring and dealing with conflicts of interest. Any relevant
interests, or changes to interests, will also be declared publicly at the start
of each guideline committee meeting. Before each meeting, any potential
conflicts of interest will be considered by the guideline committee Chair and
a senior member of the development team. Any decisions to exclude a
person from all or part of a meeting will be documented. Any changes to a
member's declaration of interests will be recorded in the minutes of the
meeting. Declarations of interests will be published with the final guideline.
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18OSAHS: DRAFT FOR CONSULTATION
Review protocols
Collaborators Development of this systematic review will be overseen by an advisory
committee who will use the review to inform the development of evidence-
based recommendations in line with section 3 of Developing NICE
guidelines: the manual. Members of the guideline committee are available
on the NICE website: https://www.nice.org.uk/guidance/indevelopment/gid-
ng10098
Other registration details NA – not registered
Reference/URL for NA – not registered
published protocol
Dissemination plans NICE may use a range of different methods to raise awareness of the
guideline. These include standard approaches such as:
• notifying registered stakeholders of publication
• publicising the guideline through NICE's newsletter and alerts
• issuing a press release or briefing as appropriate, posting news articles
on the NICE website, using social media channels, and publicising the
guideline within NICE.
Keywords -
Details of existing review NA
of same topic by same
authors
Additional information -
Details of final publication www.nice.org.uk
1
2
3 Table 3: Health economic review protocol
Review
All questions – health economic evidence
question
Objectives To identify health economic studies relevant to any of the review questions.
Search • Populations, interventions and comparators must be as specified in the clinical
criteria review protocol above.
• Studies must be of a relevant health economic study design (cost–utility analysis,
cost-effectiveness analysis, cost–benefit analysis, cost–consequences analysis,
comparative cost analysis).
• Studies must not be a letter, editorial or commentary, or a review of health
economic evaluations. (Recent reviews will be ordered although not reviewed. The
bibliographies will be checked for relevant studies, which will then be ordered.)
• Unpublished reports will not be considered unless submitted as part of a call for
evidence.
• Studies must be in English.
Search A health economic study search will be undertaken using population-specific terms
strategy and a health economic study filter – see appendix B below.
Review Studies not meeting any of the search criteria above will be excluded. Studies
strategy published before 2003, abstract-only studies and studies from non-OECD countries
or the USA will also be excluded.
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19OSAHS: DRAFT FOR CONSULTATION
Review protocols
Each remaining study will be assessed for applicability and methodological limitations
using the NICE economic evaluation checklist which can be found in appendix H of
Developing NICE guidelines: the manual (2014).34
Inclusion and exclusion criteria
• If a study is rated as both ‘Directly applicable’ and with ‘Minor limitations’ then it will
be included in the guideline. A health economic evidence table will be completed
and it will be included in the health economic evidence profile.
• If a study is rated as either ‘Not applicable’ or with ‘Very serious limitations’ then it
will usually be excluded from the guideline. If it is excluded, then a health economic
evidence table will not be completed and it will not be included in the health
economic evidence profile.
• If a study is rated as ‘Partially applicable’, with ‘Potentially serious limitations’ or
both then there is discretion over whether it should be included.
Where there is discretion
The health economist will make a decision based on the relative applicability and
quality of the available evidence for that question, in discussion with the guideline
committee if required. The ultimate aim is to include health economic studies that are
helpful for decision-making in the context of the guideline and the current NHS
setting. If several studies are considered of sufficiently high applicability and
methodological quality that they could all be included, then the health economist, in
discussion with the committee if required, may decide to include only the most
applicable studies and to selectively exclude the remaining studies. All studies
excluded on the basis of applicability or methodological limitations will be listed with
explanation in the excluded health economic studies appendix below.
The health economist will be guided by the following hierarchies.
Setting:
• UK NHS (most applicable).
• OECD countries with predominantly public health insurance systems (for example,
France, Germany, Sweden).
• OECD countries with predominantly private health insurance systems (for example,
Switzerland).
• Studies set in non-OECD countries or in the USA will be excluded before being
assessed for applicability and methodological limitations.
Health economic study type:
• Cost–utility analysis (most applicable).
• Other type of full economic evaluation (cost–benefit analysis, cost-effectiveness
analysis, cost–consequences analysis).
• Comparative cost analysis.
• Non-comparative cost analyses including cost-of-illness studies will be excluded
before being assessed for applicability and methodological limitations.
Year of analysis:
• The more recent the study, the more applicable it will be.
• Studies published in 2003 or later but that depend on unit costs and resource data
entirely or predominantly from before 2003 will be rated as ‘Not applicable’.
• Studies published before 2003 will be excluded before being assessed for
applicability and methodological limitations.
Quality and relevance of effectiveness data used in the health economic analysis:
• The more closely the clinical effectiveness data used in the health economic
analysis match with the outcomes of the studies included in the clinical review the
more useful the analysis will be for decision-making in the guideline.
© NICE 2021. All rights reserved. Subject to Notice of rights.
20OSAHS: DRAFT FOR CONSULTATION
1
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21OSAHS: DRAFT FOR CONSULTATION
Literature search strategies
1 Appendix B: Literature search strategies
2 Sleep Apnoea search strategy 2_demonstration of efficacy
3 This literature search strategy was used for the following review;
4 • How should efficacy of treatment be demonstrated (for example, variable positive
5 pressure titration device, oximetry, capnography or polysomnography titration)?
6 The literature searches for this review are detailed below and complied with the methodology
7 outlined in Developing NICE guidelines: the manual.34
8 For more information, please see the Methods Report published as part of the accompanying
9 documents for this guideline.
10 B.1 Clinical search literature search strategy
11 Searches were constructed using a PICO framework where population (P) terms were
12 combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are
13 rarely used in search strategies for interventions as these concepts may not be well
14 described in title, abstract or indexes and therefore difficult to retrieve. Search filters were
15 applied to the search where appropriate.
16 Table 4: Database date parameters and filters used
Database Dates searched Search filter used
Medline (OVID) 1946 – 6 July 2020 Exclusions
Randomised controlled trials
Systematic review studies
Observational studies
Embase (OVID) 1974 – 6 July 2020 Exclusions
Randomised controlled trials
Systematic review studies
Observational studies
The Cochrane Library (Wiley) Cochrane Reviews to 2020 None
Issue 7 of 12
CENTRAL to 2020 Issue 7 of
12
Epistemonikos (Epistemonikos Inception – 29 November 2018 None
Foundation)
17 Medline (Ovid) search terms
1. exp Sleep Apnea Syndromes/
2. (sleep* adj4 (apn?ea* or hypopn?ea*)).ti,ab.
3. (sleep* adj4 disorder* adj4 breath*).ti,ab.
4. (OSAHS or OSA or OSAS).ti,ab.
5. (obes* adj3 hypoventil*).ti,ab.
6. pickwick*.ti,ab.
7. or/1-6
8. limit 7 to English language
9. letter/
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22OSAHS: DRAFT FOR CONSULTATION
Literature search strategies
10. editorial/
11. news/
12. exp historical article/
13. Anecdotes as Topic/
14. comment/
15. case report/
16. (letter or comment*).ti.
17. or/9-16
18. randomized controlled trial/ or random*.ti,ab.
19. 17 not 18
20. animals/ not humans/
21. exp Animals, Laboratory/
22. exp Animal Experimentation/
23. exp Models, Animal/
24. exp Rodentia/
25. (rat or rats or mouse or mice).ti.
26. or/19-25
27. 8 not 26
28. (sleep* adj3 (tool* or index* or indic* or score* or scoring or scale*)).ti,ab.
29. ((spouse* or wife or wives or husband* or significant other* or partner* or family or
families or care giver* or caregiver* or carer* or symptom*) adj (report* or observ* or
watch* or note* or noting or hear* or listen*)).ti,ab.
30. (out of hours or off hours).ti,ab.
31. exp oximetry/ or capnography/ or polysomnography/
32. (oximetry or capnogra* or capnometer or polysomnograph* or colorimetr* or
conductometr* or potentiometr*).ti,ab.
33. ((carbon dioxide or CO2 or oxygen or O2) adj2 (monitor* or continuous*)).ti,ab.
34. (blood gas adj2 (monitor* or continuous or test*)).ti,ab.
35. Epworth Sleepiness Scale.ti,ab.
36. Apnoea Hypopnea Index.ti,ab.
37. Oxygen desaturation index.ti,ab.
38. Calgary Sleep Apnea Quality of Life Index.ti,ab.
39. (ESS or AHI or ODI or SQALI or ABG).ti,ab.
40. or/28-39
41. 27 and 40
42. Meta-Analysis/
43. exp Meta-Analysis as Topic/
44. (meta analy* or metanaly* or metaanaly* or meta regression).ti,ab.
45. ((systematic* or evidence*) adj3 (review* or overview*)).ti,ab.
46. (reference list* or bibliograph* or hand search* or manual search* or relevant
journals).ab.
47. (search strategy or search criteria or systematic search or study selection or data
extraction).ab.
48. (search* adj4 literature).ab.
49. (medline or pubmed or cochrane or embase or psychlit or psyclit or psychinfo or
psycinfo or cinahl or science citation index or bids or cancerlit).ab.
50. cochrane.jw.
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23OSAHS: DRAFT FOR CONSULTATION
Literature search strategies
51. ((multiple treatment* or indirect or mixed) adj2 comparison*).ti,ab.
52. or/42-51
53. randomized controlled trial.pt.
54. controlled clinical trial.pt.
55. randomi#ed.ti,ab.
56. placebo.ab.
57. randomly.ti,ab.
58. Clinical Trials as topic.sh.
59. trial.ti.
60. or/53-59
61. Epidemiologic studies/
62. Observational study/
63. exp Cohort studies/
64. (cohort adj (study or studies or analys* or data)).ti,ab.
65. ((follow up or observational or uncontrolled or non randomi#ed or epidemiologic*) adj
(study or studies or data)).ti,ab.
66. ((longitudinal or retrospective or prospective or cross sectional) and (study or studies or
review or analys* or cohort* or data)).ti,ab.
67. Controlled Before-After Studies/
68. Historically Controlled Study/
69. Interrupted Time Series Analysis/
70. (before adj2 after adj2 (study or studies or data)).ti,ab.
71. exp case control study/
72. case control*.ti,ab.
73. Cross-sectional studies/
74. (cross sectional and (study or studies or review or analys* or cohort* or data)).ti,ab.
75. or/61-74
76. 41 and (52 or 60 or 75)
1 Embase (Ovid) search terms
1. exp Sleep Disordered Breathing/
2. (sleep* adj4 (apn?ea* or hypopn?ea*)).ti,ab.
3. (sleep* adj4 disorder* adj4 breath*).ti,ab.
4. (OSAHS or OSA or OSAS).ti,ab.
5. (obes* adj3 hypoventil*).ti,ab.
6. pickwick*.ti,ab.
7. or/1-6
8. limit 7 to English language
9. letter.pt. or letter/
10. note.pt.
11. editorial.pt.
12. case report/ or case study/
13. (letter or comment*).ti.
14. or/9-13
15. randomized controlled trial/ or random*.ti,ab.
16. 14 not 15
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24OSAHS: DRAFT FOR CONSULTATION
Literature search strategies
17. animal/ not human/
18. nonhuman/
19. exp Animal Experiment/
20. exp Experimental Animal/
21. animal model/
22. exp Rodent/
23. (rat or rats or mouse or mice).ti.
24. or/16-23
25. 8 not 24
26. (sleep* adj3 (tool* or index* or indic* or score* or scoring or scale*)).ti,ab.
27. ((spouse* or wife or wives or husband* or significant other* or partner* or family or
families or care giver* or caregiver* or carer* or symptom*) adj (report* or observ* or
watch* or note* or noting or hear* or listen*)).ti,ab.
28. (out of hours or off hours).ti,ab.
29. exp oximetry/ or exp capnometry/ or caponometer/ or polysomnography/
30. (oximetry or capnogra* or capnometer or polysomnograph* or colorimetr* or
conductometr* or potentiometr*).ti,ab.
31. ((carbon dioxide or CO2 or oxygen or O2) adj2 (monitor* or continuous*)).ti,ab.
32. (blood gas adj2 (monitor* or continuous or test*)).ti,ab.
33. Epworth Sleepiness Scale.ti,ab.
34. Apnoea Hypopnea Index.ti,ab.
35. Oxygen desaturation index.ti,ab.
36. Calgary Sleep Apnea Quality of Life Index.ti,ab.
37. (ESS or AHI or ODI or SQALI or ABG).ti,ab.
38. or/26-37
39. 25 and 38
40. systematic review/
41. meta-analysis/
42. (meta analy* or metanaly* or metaanaly* or meta regression).ti,ab.
43. ((systematic* or evidence*) adj3 (review* or overview*)).ti,ab.
44. (reference list* or bibliograph* or hand search* or manual search* or relevant
journals).ab.
45. (search strategy or search criteria or systematic search or study selection or data
extraction).ab.
46. (search* adj4 literature).ab.
47. (medline or pubmed or cochrane or embase or psychlit or psyclit or psychinfo or
psycinfo or cinahl or science citation index or bids or cancerlit).ab.
48. cochrane.jw.
49. ((multiple treatment* or indirect or mixed) adj2 comparison*).ti,ab.
50. or/40-49
51. random*.ti,ab.
52. factorial*.ti,ab.
53. (crossover* or cross over*).ti,ab.
54. ((doubl* or singl*) adj blind*).ti,ab.
55. (assign* or allocat* or volunteer* or placebo*).ti,ab.
56. crossover procedure/
57. single blind procedure/
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